FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
MIS CONNECT Conical Connection Abutment
K Number: K173326
·
Decision Mar 16, 2018
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
13
Review Days
147
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Basic Information
- Device Name
- MIS CONNECT Conical Connection Abutment
- K Number
- K173326
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mis Implants Technologies , Ltd.
- Date Received
- October 20, 2017
- Decision Date
- March 16, 2018
- Product Code
- NHA
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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Other Clearances by Mis Implants Technologies , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K182228 | MIS LOCKiT Abutments System, OT-Equators and Ball Attachments | Jan 28, 2019 | Substantially Equivalent |
| K180282 | MIS Internal Hex Dental Implant System | Jun 22, 2018 | Substantially Equivalent |
| K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments | Dec 28, 2017 | Substantially Equivalent |
| K163349 | MIS V3 Conical Connection Dental Implant System | May 26, 2017 | Substantially Equivalent |
| K112162 | CONICAL CONNECTION IMPLANTS | Aug 8, 2012 | Substantially Equivalent |
| K110750 | PERIOPATCH | Apr 28, 2011 | Substantially Equivalent |
| K101014 | BOND BONE | Oct 21, 2010 | Substantially Equivalent |
| K092555 | UNO NARROW IMPLANT | Jan 5, 2010 | Substantially Equivalent |
| K080162 | UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT | Apr 22, 2008 | Substantially Equivalent |
| K073461 | ORTHO ANCHOR SCREWS | Jan 25, 2008 | Substantially Equivalent |